글로벌 실험실 개발 테스트(LDT) 시장 – 2031년까지의 산업 동향 및 예측

실험실에서 개발된 테스트(LDT) 시장 분석 및 규모.

LDT는 상업적으로 이용 가능하지 않은 검사가 필요하거나 기존 검사가 특정 환자 집단의 특정 요구 사항을 충족하지 못하는 경우에 자주 사용됩니다. LDT를 개발하는 실험실은 검사의 정확성, 신뢰성 및 임상적 타당성을 보장하고 규제 요구 사항 및 품질 표준을 준수할 책임이 있습니다. LDT는 실험실이 개별 환자의 특정 요구 사항에 맞게 검사를 맞춤화할 수 있으므로 개인화된 의학 및 정밀 진단을 발전시키는 데 중요한 역할을 했습니다.

Data Bridge Market Research는 2023년에 121억 3천만 달러였던 글로벌 실험실 개발 테스트(LDT) 시장이 2031년까지 273억 6천만 달러에 도달할 것으로 분석했으며, 2024년부터 2031년까지의 예측 기간 동안 10.7%의 CAGR을 기록할 것으로 예상합니다. Data Bridge Market Research에서 큐레이팅한 시장 보고서에는 시장 가치, 성장률, 세분화, 지리적 범위, 주요 업체와 같은 시장 시나리오에 대한 통찰력 외에도 심층 전문가 분석, 환자 역학, 파이프라인 분석, 가격 분석 및 규제 프레임워크도 포함됩니다.

보고 범위 및 시장 세분화      

시장 정의

실험실에서 개발한 검사(LDT)는 사내에서 개발한 검사 또는 홈브루 검사라고도 하며, 특정 임상 목적을 위해 개별 실험실에서 개발하고 수행하는 진단 검사 입니다 . 이러한 검사는 일반적으로 질병이나 상태와 관련된 특정 바이오마커, 유전자 돌연변이 또는 기타 분자적 또는 세포적 특성의 존재를 탐지하고 측정하도록 설계되었습니다. 진단 회사에서 제조하고 판매하는 상용 검사와 달리 LDT는 단일 실험실 내에서 개발, 검증 및 수행됩니다.

글로벌 실험실 개발 테스트(LDT) 시장 역학

운전자

• 분자 진단의 발전

중합효소 연쇄 반응 (PCR), 차세대 시퀀싱(NGS) , 유전자 발현 프로파일링과 같은 분자 기술은 진단 검사에 혁명을 일으켜 질병과 상태를 보다 정확하고 정밀하게 탐지할 수 있게 했습니다. 이러한 발전으로 실험실은 보다 정교하고 타겟팅된 LDT를 개발할 수 있었고, 이는 시장 성장을 촉진했습니다.

• 개인화된 의학에 대한 수요 증가

개인화된 의학에 대한 수요가 증가하는 것도 시장 성장에 기여했습니다. 개인화된 의학은 유전적 구성, 라이프스타일, 환경을 포함하여 각 환자의 개별적 특성에 맞게 치료를 맞춤화하는 것을 목표로 합니다. LDT는 의료 제공자가 환자 치료 계획을 맞춤화하는 데 도움이 되는 진단 정보를 제공함으로써 개인화된 의학에서 중요한 역할을 합니다. 개인화된 의학이 더욱 대중화됨에 따라 LDT에 대한 수요는 계속 증가할 것입니다.

• 만성 질환의 유병률 증가

The increasing prevalence of chronic diseases such as cancer, cardiovascular diseases, and diabetes has led to a growing need for more accurate and reliable diagnostic tests. LDTs can play a key role in the early detection and monitoring of chronic diseases, helping to improve patient outcomes and reduce healthcare costs. The rising burden of chronic diseases worldwide is driving the demand for LDTs and fueling growth in the market.

Opportunities

• Increasing Focus on Early Disease Detection

Early disease detection is a growing focus as a key strategy for improving patient outcomes and reducing healthcare costs. Early detection allows for timely intervention and treatment, which can significantly improve the chances of successful outcomes. LDTs are well-suited for early disease detection, as they can be developed and validated quickly to target specific biomarkers or disease indicators. The increasing emphasis on early detection is driving the demand for LDTs and creating new opportunities for market growth.

• Increasing Adoption of Point-of-Care Testing

The increasing adoption of point-of-care testing (POCT) is creating new opportunities for the market. POCT allows for rapid diagnostic testing at or near the site of patient care, enabling healthcare providers to make immediate treatment decisions. LDTs are well-suited for POCT, as they can be developed and validated quickly for use in decentralized settings. The growing demand for POCT is driving the need for new LDTs that can be used in these settings, creating new opportunities for market growth.

Restraints/Challenges

• Fluctuating and Intricate Regulatory Environment

One of the significant challenges facing the market is the complex and evolving regulatory landscape. Different countries have varying regulations regarding LDTs, with some jurisdictions imposing strict restrictions or requiring extensive validation and oversight. These regulatory challenges can hinder the market's growth by increasing the cost and time required to develop and launch new LDTs, and creating uncertainty for laboratories and healthcare providers.

• Quality Control and Standardization

Ensuring the quality and consistency of LDTs can be challenging, particularly for laboratories that may not have access to standardized reagents and protocols. Variability in testing methodologies and results can lead to discrepancies in patient care and may undermine the credibility of LDTs. Establishing quality control measures and standardization protocols for LDTs is essential but can be resource-intensive and time-consuming, posing a challenge to market growth.

• Competition from Commercially Available Tests

The availability of commercially available tests for many diseases and conditions can challenge the global LDTs market. Commercial tests often undergo rigorous validation and regulatory approval processes, giving them a perceived advantage regarding reliability and credibility. Laboratories developing LDTs may struggle to compete with these commercially available tests, particularly in gaining acceptance from healthcare providers and payers.

This laboratory-developed tests (LDTs) market report provides details of new recent developments, trade regulations, import-export analysis, production analysis, value chain optimization, market share, impact of domestic and localized market players, analyses opportunities in terms of emerging revenue pockets, changes in market regulations, strategic market growth analysis, market size, category market growths, application niches and dominance, product approvals, product launches, geographic expansions, technological innovations in the market. To gain more info on the laboratory-developed tests (LDTs) market contact Data Bridge Market Research for an Analyst Brief, our team will help you take an informed market decision to achieve market growth.

Recent Developments

• In February 2023, Guardant Health disclosed that United Healthcare would cover its Guardant360 CDx blood test as a companion diagnostic for advanced lung and breast cancer. This development facilitated the company's expansion of its global footprint
• In May 2022, OPKO Health, Inc. purchased ModeX Therapeutics, a privately held biotechnology firm concentrating on creating innovative multi-specific immune therapies for cancer and infectious diseases. This acquisition aided the company in establishing its global network

Global Laboratory-Developed Tests (LDTs) Market Scope

The laboratory-developed tests (LDTs) market is segmented into eight notable segments based on test type, product type, sample type, therapeutic area, gender, age group, end user, and distribution channel. The growth among segments helps you analyze niche pockets of growth and strategies to approach the market and determine your core application areas and the difference in your target markets.

Test Type

• Clinical Chemistry and Immunology
• Critical Care
• Hematology
• Molecular Diagnostics
• Microbiology
• Other Test

Product Type

• Consumables
• Analyzers and Instruments
• Accessories

Sample Type

• Blood
• Urine
• Tissue
• Cerebrospinal fluid (CSF)
• Others

Therapeutic Area

• Infections
• Genetic Disorders
• Oncology/Cancer
• Autoimmune Disease
• Urology
• Gynecology
• Others

Gender

• Male
• Female

Age Group

• Geriatrics
• Adults
• Pediatric

End User

• Hospital-Based Labs
• Stand-Alone Labs
• Diagnostic Chains
• Academic Institutes
• Clinical Research Organizations
• Specialty Diagnostic Centers
• Others

Distribution Channel

• Direct Tender
• Retail Slaes
• Third Party Distribution
• Others

Global Laboratory-Developed Tests (LDTs) Market Regional Analysis/Insights

The laboratory-developed tests (LDTs) market is analyzed and market size insights and trends are provided by country, test type, product type, sample type, therapeutic area, gender, age group, end user, and distribution channel as referenced above.

The countries covered in the the market are U.S., Canada, Mexico, Germany, France, U.K., Netherlands, Switzerland, Belgium, Russia, Italy, Spain, Turkey, Rest of Europe, China, Japan, India, South Korea, Singapore, Malaysia, Australia, Thailand, Indonesia, Philippines, Rest of Asia-Pacific, Saudi Arabia, U.A.E., South Africa, Egypt, Israel, Rest of Middle East and Africa, Brazil, Argentina, and Rest of South America.

North America is expected to dominate the market and be the fastest growing region due to the rise in healthcare spending, the increasing incidence of chronic diseases, the expanding elderly population, and growing government funding.

Top of Form

The country section of the report also provides individual market impacting factors and changes in regulation in the market domestically that impacts the current and future trends of the market. Data points like down-stream and upstream value chain analysis, technical trends and porter's five forces analysis, case studies are some of the pointers used to forecast the market scenario for individual countries. Also, the presence and availability of global brands and their challenges faced due to large or scarce competition from local and domestic brands, impact of domestic tariffs and trade routes are considered while providing forecast analysis of the country data.

Healthcare Infrastructure Growth Installed base and New Technology Penetration

The laboratory-developed tests (LDTs) market also provides you with detailed market analysis for every country growth in healthcare expenditure for capital equipment, installed base of different kind of products for laboratory-developed tests (LDTs) market, impact of technology using life line curves and changes in healthcare regulatory scenarios and their impact on the laboratory-developed tests (LDTs) market. The data is available for historic period 2016-2021.

Competitive Landscape and Global Laboratory-Developed Tests (LDTs) Market Share Analysis

The laboratory-developed tests (LDTs) market competitive landscape provides details by competitor. Details included are company overview, company financials, revenue generated, market potential, investment in research and development, new market initiatives, global presence, production sites and facilities, production capacities, company strengths and weaknesses, product launch, product width and breadth, application dominance. The above data points provided are only related to the companies' focus related to laboratory-developed tests (LDTs) market.

Some of the major players operating in the laboratory-developed tests (LDTs) market are:

• Roche,(Switzerland)
• bioMérieux,(France)
• Sysmex Corporation (Japan)
• Biomerica, Inc.,(U.S.)
• Bio, Rad Laboratories, Inc.,(U.S.)
• BD(Becton, Dickinson and Company),(미국)
• Quest Diagnostics Incorporated,(미국) 
• Hologic, Inc.(미국)
• Siemens Medical Solutions USA, Inc.(미국)
• 애벗(미국)
• Eurofins Scientific(미국)
• Beckman Coulter, Inc.(미국)
• 23andMe, Inc.(미국)
• OPKO Health, Inc.(미국)

SKU-54116